Adherence to Treatment in Egyptian Patients With Knee Osteoarthritis (OA)

January 22, 2024 updated by: Amany Mohammed Ibrahim Ebaid, Zagazig University

Impact Of Health Education Program on Adherence to Treatment in Egyptian Patients With Knee Osteoarthritis

the aim is to measure the level of adherence of knee osteoartheritis patients to a Carefully curated program that follows the American College of Rheumatology/Arthritis (ACR) recommendation guidelines and investigate the factor that might affect the patient's adherence to the prescribed protocol.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

2.3. interventional protocol (for intervention group only): For the Intervention group: A face-to-face semi-structured interview was carried out with each participant separately. The interview (30-45minuts) included a health education program explaining the nature of the condition(KOA causes, pathological changes, and natural course of the disease), we explained the recommendations for the treatment of KOA, teaching the patient a home exercise program of 5 exercises (targeting knee extensor and hip muscle ), selection of a physiotherapy program suitable to the patient clinical condition, recommendations to increase daily physical activity ( e.g. brisk walking) with joint protection measures along with a weight reduction regimen proposed in overweight and obese patients and prescribing a suitable pharmacological treatment to the patients mentioning side effect that might occur. At the end of the interview, each participant received a booklet including the recommendations for the treatment of knee osteoarthritis according to the ACR.

As for the control group, they were assigned the traditional approach for KOA management, they were told their diagnosis if they were not already familiar with it, received the treatment for KOA according to ACR guidelines, they were offered physical therapy modalities if their condition required but they were not given the health education program or the other interventional steps.

2.4. Follow-up period: Throughout the following three months after enrollment, participants were followed up every ten days; asking about persistence on the prescribed treatment and exercise program, the level of their daily activity, and their diet plan. For participants who failed to attend for any reason, a telephone call was performed to provide behavior change support in both groups. The telephone call aimed to observe adherence to treatment in the control group and to increase levels of participation in the intervention group.

Study Type

Interventional

Enrollment (Actual)

154

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • El Sharkia
      • Zagazig, El Sharkia, Egypt, 44511
        • Zagazig University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • diagnosed as having knee osteoarthritis according to the American College of Rheumatology criteria

Exclusion Criteria:

  • Patients with a

    1. A history of knee trauma or injury
    2. patients suffering from any other rheumatological diseases (e.g., Rheumatoid Arthritis)
    3. severe comorbidities, severe cardiovascular disease, heart failure, gastrointestinal bleeding risk, and chronic kidney disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: intervention group
health education program explaining the nature of the condition(KOA causes, pathological changes, and natural course of the disease), we explained the recommendations for the treatment of KOA, teaching the patient a home exercise program of 5 exercises (targeting knee extensor and hip muscle ), selection of a physiotherapy program suitable to the patient clinical condition, recommendations to increase daily physical activity ( e.g. brisk walking) with joint protection measures along with a weight reduction regimen proposed in overweight and obese patients and prescribing a suitable pharmacological treatment to the patients
Behavioral: health education
adherence to treatment
Other Names:
  • exercise and diet plan
No Intervention: control group
were assigned the traditional approach for KOA management, they were told their diagnosis if they were not already familiar with it, received the treatment for KOA according to ACR guidelines, they were offered physical therapy modalities if their condition required but they were not given the health education program or the other interventional steps.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measuring KOA patients adherence
Time Frame: 3 months
adherence survey based on morsiky adherence scale
3 months
improved patients function and improved patient pain
Time Frame: 3 MONTHS

measured by Western Ontario and McMaster University Osteoarthritis Index contains 5 items that address the following person-level activities: walking, stair climbing, sitting, lying down, and standing

--measured by visual analog scale
3 MONTHS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
investigating the factors that hinder patient adherence
Time Frame: 3 months
WHO frame work foe adherence
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2023

Primary Completion (Actual)

May 24, 2023

Study Completion (Actual)

September 1, 2023

Study Registration Dates

First Submitted

September 24, 2023

First Submitted That Met QC Criteria

September 28, 2023

First Posted (Actual)

October 3, 2023

Study Record Updates

Last Update Posted (Actual)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB #:4677

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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